Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
1 other identifier
interventional
416
1 country
2
Brief Summary
To demonstrate the non-inferiority of Ilaprazole 10 mg to the active control in prevention of NSAIDs-associated peptic ulcer, as assessed by the proportion of subjects with peptic ulcer by Week 24
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2024
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2024
CompletedFirst Posted
Study publicly available on registry
February 29, 2024
CompletedStudy Start
First participant enrolled
July 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
May 30, 2025
May 1, 2025
2.1 years
February 21, 2024
May 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Ilaprazole, Lansoprazole peptic ulcer
Proportion of subjects with newly developed peptic ulcer until Week 24 after the IP treatment
at 24 weeks
Secondary Outcomes (2)
Ilaprazole, Lansoprazole peptic ulcer
at 12 weeks
Ilaprazole, Lansoprazole GI bleeding
at 12, 24 weeks
Study Arms (2)
Ilaprazole 10 mg
EXPERIMENTALTake Ilaprazole 10 mg 1 tablet + Placebo of Lansoprazole 15 mg 1 capsule by mouth, with water, once daily.
Lansoprazole 15 mg
ACTIVE COMPARATORTake Lansoprazole 15 mg 1 capsule + Placebo of Ilaprazole 10 mg 1 tablet by mouth, with water, once daily.
Interventions
Placebo of Ilaprazole 10 mg
Placebo of Lansoprazole 15 mg
Eligibility Criteria
You may qualify if:
- Adult males and females aged 19 years or older on the day of informed consent
- Subjects requiring continuous treatment or receiving treatment with NSAIDs
- Subjects with at least one of following peptic ulcer risk factors at the time of Screening
- Subjects who have provided voluntary informed consent for the study participation after the study is explained
You may not qualify if:
- Subjects with Gastroesophageal varices, Esophageal stricture or ulcerous stenosis, Gastrointestinal bleeding or perforation, Esophageal dysplasia and else based on the screening EGD results.
- Subjects with inflammatory bowel diseases, pancreatitis, pyloric obstruction, and primary esophageal motility disorder
- Subjects with confirmed history of malignancy within 5 years prior to Screening
- Positive human immunodeficiency virus (HIV) antigen/antibody at Screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Chung Ang University Hospital
Seoul, South Korea
Chung-Ang University Hospital
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
JungSoo Song, M.D.
Chung-Ang University Hospital Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2024
First Posted
February 29, 2024
Study Start
July 23, 2024
Primary Completion (Estimated)
August 30, 2026
Study Completion (Estimated)
February 28, 2027
Last Updated
May 30, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share